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Guidelines

24.09.2019 Updated 21.07.2026 437859 views
Guideline ST-N MOHU 42-7.6:2026 "Medicinal Products. Validation of Bioanalytical Method and Analysis of Study Samples (ICH M10)"PDF · 1.2 MB · 21.07.2026
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Guideline ‘Medicinal Products. Good Clinical Practice (GCP) ICH E6 (R3). ST-N MOZU 42–7.18:2025’, approved by Order of the Ministry of Health No. 1686 of 05.11.2025PDF · 1.4 MB · 14.11.2025
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Guideline ST-N MOHU 42-8.6:2025 “Medicinal products. Requirements for quality documentation for biological investigational medicinal products within clinical trials”PDF · 1.4 MB · 03.10.2025
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Guideline ST-N MOHU 42 – 9.1:2024 “Medicinal products. Requirements for the dossier of investigational advanced therapy medicinal products within clinical trials”PDF · 1.2 MB · 19.11.2024
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Guideline. Medicinal products. Requirements for documentation on the chemical and pharmaceutical quality of medicinal products in clinical trialsPDF · 635 KB · 18.06.2024
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Medicinal products. Classification of advanced therapy medicinal productsPDF · 1.2 MB · 28.03.2024
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Medicinal products. Proof of bioequivalence under the biowaiver procedure based on the Biopharmaceutics Classification SystemPDF · 497 KB · 13.02.2024
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IN VITRO STUDIES OF DRUG INTERACTIONS MEDIATED BY CYTOCHROME P450 ISOENZYMESPDF · 808 KB · 07.11.2023
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Guideline CT-N MoHU 42–6.2:2021 “MEDICINAL PRODUCTS. PRECLINICAL EVALUATION OF VACCINES”PDF · 708 KB · 26.08.2021
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Guideline ST-N MoHU 42-7.9:2021 “MEDICINAL PRODUCTS. PRECLINICAL SAFETY STUDIES TO SUPPORT THE DEVELOPMENT OF MEDICINAL PRODUCTS FOR PEDIATRIC USE”DOCX · 2.2 MB · 22.04.2021
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Guidelines ST-N MOHU 42-7.8:2021 “MEDICINAL PRODUCTS. BIOANALYTICAL PART OF THE STUDY”PDF · 968 KB · 05.04.2021
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NATIONAL FOREWORDPDF · 647 KB · 25.01.2021
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GUIDELINE. MEDICINAL PRODUCTS. GOOD PHARMACOVIGILANCE PRACTICESPDF · 5 MB · 25.01.2021
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MEDICINAL PRODUCTS. VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN (Q5A (R1)).PDF · 707 KB · 25.01.2021
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MEDICINAL PRODUCTS. GOOD PHARMACOVIGILANCE PRACTICES. MODULES I-IV.DOC · 933 KB · 25.01.2021
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MEDICINAL PRODUCTS. SIMILAR BIOLOGICAL PRODUCTS CONTAINING MONOCLONAL ANTIBODIES – NONCLINICAL AND CLINICAL ISSUESPDF · 621 KB · 25.01.2021
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MEDICINAL PRODUCTS. ASSESSMENT OF THE IMMUNOGENICITY OF MONOCLONAL ANTIBODIES INTENDED FOR IN VIVO CLINICAL USEPDF · 649 KB · 25.01.2021
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MEDICINAL PRODUCTS. DEVELOPMENT, MANUFACTURE, CHARACTERIZATION AND SPECIFICATIONS OF MONOCLONAL ANTIBODIES AND RELATED PRODUCTSPDF · 555 KB · 25.01.2021
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STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTSPDF · 533 KB · 25.01.2021
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SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTSPDF · 684 KB · 25.01.2021
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SPECIFICS OF BIOLOGICAL/BIOTECHNOLOGICAL PRODUCTS AND BIOSIMILARS (METHODOLOGICAL RECOMMENDATIONS)PDF · 488 KB · 25.01.2021
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SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCESPDF · 588 KB · 25.01.2021
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COMPARABILITY OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS PHARMACEUTICAL DEVELOPMENT OF BIOTECHNOLOGICAL AND BIOLOGICAL PRODUCTSPDF · 452 KB · 25.01.2021
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PRECLINICAL SAFETY EVALUATION OF MEDICINAL PRODUCTS OF BIOTECHNOLOGICAL ORIGIN (METHODOLOGICAL RECOMMENDATIONS)PDF · 266 KB · 25.01.2021
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GENERAL PRINCIPLES OF PRECLINICAL AND CLINICAL STUDIES OF BIOSIMILAR MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS THE ACTIVE SUBSTANCEPDF · 536 KB · 25.01.2021
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PLASTIC MATERIALS FOR PRIMARY PACKAGING OF MEDICINAL PRODUCTSPDF · 500 KB · 25.01.2021
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PHARMACEUTICAL DEVELOPMENT OF MEDICINAL PRODUCTS FOR PEDIATRIC USEPDF · 683 KB · 25.01.2021
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GUIDELINE MEDICINAL PRODUCTS NONCLINICAL SAFETY STUDIES TO SUPPORT CLINICAL TRIALS IN HUMANS AND MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS (ICHM3(R2))PDF · 619 KB · 25.01.2021
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GUIDELINE. MEDICINAL PRODUCTS. GUIDANCE ON THE CLINICAL EVALUATION OF VACCINESPDF · 2.7 MB · 25.01.2021
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Guideline on bioequivalence studiesPDF · 1.7 MB · 20.12.2022
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Latest updates

List of registration forms submitted for state re-registration in the period from 28.09.2026 to 02.10.2026
# For applicants # List of applications for state registration of medicinal products
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List of registration forms submitted for state registration in the period from 28.09.2026 to 02.10.2026
# For applicants # List of applications for state registration of medicinal products
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Registration certificates to order No. 1340
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Competitive selection of members of the HTA Expert Committee: deadline for submitting documents – until 12 October 2026

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Updated! List of original (innovative) medicinal products registered in Ukraine as of 07.09.2026

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Attention to business entities engaged in retail trade of medicinal products on the market of Ukraine! We provide lists of over-the-counter medicinal products by their storage conditions

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Representatives of the Center exchanged experience in the field of HTA with Swedish colleagues

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